Journal of Developing Drugs
Open Access

Inspection and audit readiness for medical devices

2^nd International Summit on GMP, GCP & Quality Control

November 12-14, 2013 DoubleTree by Hilton Hotel Chicago-North Shore, IL, USA

J. Andrew Harrison

Accepted Abstracts: J Develop Drugs

Abstract :

Our Role & Responsibilities in the Regulated Industry ? What to expect during a medical device FDA inspection ? General ground rules for inspection management that builds rapport with auditors ? Examples of critical mis-steps made during inspections ? Navigating known risks and other gray areas ethically and with professionalism Understanding the Myriad of Inspection Methodologies ? Paths routinely used by investigators/auditors during inspections ? Modeling your internal audit program to position your firm for inspection success ? Incorporating learning from mock audits into your firm?s readiness toolkit Establishing a Dynamic Inspection Readiness Model ? Selecting and training an inspection readiness core team ? Tools & resources to operationalize inspection management ? Prepping and presenting ?hot stories? effectively ? Points-to-consider for US-based or OUS-based audits ? Operationalizing the requirement that records/data need be ?readily available for inspection? ? Skills needed to adequately fulfill front room/war room roles & responsibilities ? Points-to-consider for establishing an effective internal audit program